Anthem and AMH Health, LLC review the activities of the FDA’s approval of drugs and biologics on a regular basis to understand the potential effects for both our providers and members.


The FDA approves new drugs/biologics using various pathways of approval. Recent studies on the effectiveness of drugs/biologics going through these different FDA pathways illustrates the importance of clinicians being aware of the clinical data behind a drug or biologic approval in making informed decisions.


Here is a list of the approval pathways the FDA uses for drugs/biologics:


  • Standard review – The standard review process follows well-established paths to help ensure drugs/biologics are safe and effective when they reach the public. From concept to approval and beyond, FDA performs these steps: reviews research data and information about drugs and biologics before they become available to the public; watches for problems once drugs and biologics are available to the public; monitors drug/biologic information and advertising; and protects drug/biologic quality. Learn more about the standard review process.


New molecular entities approvals: January - August 2020

Certain drugs/biologics are classified as new molecular entities (NMEs) for purposes of FDA review. Many of these products contain active ingredients that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients.


Anthem and AMH Health review the FDA-approved NMEs on a regular basis. To help facilitate the decision-making process, please see the attached PDF list of NMEs approved from January to August 2020 along with the FDA approval pathway utilized.






Featured In:
November 2020 Anthem Maine Provider News